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Lean Used to Lay Groundwork for Lab’s 15189 Accreditation

CEO SUMMARY: Henry Ford Health System’s laboratory organization has become first in the nation to have all its laboratory sites “standardized under one source of leadership” and accredited to the standards of ISO 15189: Medical Laboratories. The journey to achieve this current state…

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Across the Pond, Lots of Changes in Lab Testing

IN BOTH THE UNITED KINGDOM AND EUROPE, plenty of change is unfolding in clinical laboratory and anatomic pathology testing. Our intrepid Editor-in-Chief, Robert L. Michel, spent last week in England attending our annual Frontiers in Laboratory Medicine conference, now in its eleventh year. …

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New Blue Card Policies Cause Labs to Go Unpaid

CEO SUMMARY: Widespread frustration continues within the independent clinical laboratory community about the new Blue Card rules that took effect in October 2012. That was when the Blue Cross Blue Shield Association revised its Blue Card program so that labs must bill the local plan in th…

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Tricare, DOD Not Paying for MoPath Codes, LDTs

CEO SUMMARY: It turns out that labs serving Tricare patients are going unpaid for certain LDTs, molecular, and genetic tests. The issue of nonpayment began in January 2013 when Tricare stopped paying for these tests that were billed under the new molecular CPT codes that replaced the prev…

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CMS Cuts BRCA Price by 49% in Response to Competition

IN THE FINAL WEEKS OF 2013, the federal Centers for Medicare & Medicaid Services (CMS) announced that it would reduce the price it pays for the BRCA genetic test by 49%, to $1,438, effective on January 1, 2014. For Myriad Genetics, Inc., this wa…

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Claritas Is Example of New Lab Business Model

CEO SUMMARY: One by one, new business models for clinical laboratory testing are popping up. Each is a response to healthcare’s rapid evolution, the ongoing decline in lab test reimbursement, and the growing role for molecular diagnostics and genetic testing. In Cambridge, Massachusetts…

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Sonora Quest Builds EMPI To Serve Patients and ACOs

CEO SUMMARY: Probably no state has seen a faster transition to ACOs, medical homes, and other types of integrated clinical care organizations than Arizona. Recognizing that this change created a new opportunity to add more value with clinical lab testing services, Sonora Quest Laboratorie…

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Genetic Testing Creates New Legal Risks for Labs

CEO SUMMARY: Last month, in Seattle, Washington, a jury ordered Laboratory Corporation of America and Valley Medical Center each to pay $25 million following a lawsuit about a ‘wrongful’ birth. At issue was how genetic tests were ordered, performed, and reported. This court case is th…

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When Should Labs Become ‘Patient-centric?’

AS THE AMERICAN HEALTHCARE SYSTEM MOVES FORWARD with its transformation, several trends make it advisable that clinical labs and pathology groups consider the importance of becoming “patient-centric.” First, patients are being incentivized to become price shoppers and select their providers—in…

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Hospital and LabCorp Hit with $50 Million Verdict

LAWYERS CALL IT A ‘WRONGFUL BIRTH.’ When no one spots an error in prenatal genetic testing processes, a wrongful birth can result, and that’s what happened in a case that ended last month with a jury award of $50 million to a family in Burien, Washington. Defendants Valley Medical Cent…

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